Amnion Chorion Membrane Combined With Allograft Bone Putty for the Management of Intrabony Defects

NCT05922527 | Completed

• 1 other identifier: PERIO2:5:1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The ultimate goal for periodontal management is to obtain true periodontal regeneration. Periodontal regeneration implies that CAL gain is achieved through the formation of new cementum and new inserted periodontal ligaments, accompanied by alveolar bone formation, thus a whole new periodontal apparatus is reconstructed. Combined periodontal regenerative therapy; including bone grafting are considered a viable treatment option and result in significantly better clinical outcomes in intrabony defects compared to monotherapy. This study was conducted as a randomized controlled clinical trial to evaluate clinically and radiographically the possible predictable results regarding the use of amnion chorion allograft (ACM) barrier and demineralized freeze dried bone allograft, (DFDBA) versus open flap debridement (OFD) in treatment of periodontal intrabony defects.

Conditions

Periodontal Regeneration

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level gain

  clinical attachment level gain intragroup and intergroup, measured clinically in mm using periodontal probe

  6 months

Secondary Outcomes (2)

• Probing Pocket Depth Change

  6 months

• Bone defect area

  6 months

Study Arms (2)

Combined regenerative technique

EXPERIMENTAL

Open flap debridement combined with Amnion Chorion Membrane and DFDBA

Procedure: Combined regenerative technique

Open flap debridement

ACTIVE COMPARATOR

Open flap debridement

Procedure: Open flap debridement

Interventions

Combined regenerative technique PROCEDURE

Periodontal regenerative technique using amnion chorion membrane combined with DFDBA in a putty form

Combined regenerative technique

Open flap debridement PROCEDURE

Open flap debridement

Open flap debridement

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mature permanent tooth.
• Tooth with two or three-walled intra-bony defect, PPD ≥ 5mm with intra osseous defect ≥ 3mm.
• Good oral hygiene.
• Compliance with the maintenance program.
• Accepted the 6 months follow-up period.

You may not qualify if:

• Teeth with one wall intra-bony defect or supra-bony defects.
• Teeth with grade II or III mobility.
• Teeth with proximal carious defects or proximal faulty restorations.
• Medically compromised patients.
• Pregnant or nursing women.
• Smokers.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 28, 2023
• Study Start: September 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: August 20, 2022
• Last Updated: August 16, 2023

Record last verified: 2023-08

Locations

EG (1)